{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hyderabad",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091240"
        ],
        "brand_name": [
          "INDOMETHACIN"
        ],
        "generic_name": [
          "INDOMETHACIN"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-542",
          "31722-543"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "INDOMETHACIN"
        ],
        "rxcui": [
          "197817",
          "197818"
        ],
        "spl_id": [
          "349de484-29cd-3e15-e063-6394a90a5aa5"
        ],
        "spl_set_id": [
          "1ce9c3c5-0cf7-4760-988d-2559adcfb200"
        ],
        "package_ndc": [
          "31722-542-30",
          "31722-542-01",
          "31722-542-05",
          "31722-542-10",
          "31722-543-30",
          "31722-543-01",
          "31722-543-05",
          "31722-543-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722543019",
          "0331722542012"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "XXE1CET956"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80589",
      "recalling_firm": "Hetero Labs, Ltd. - Unit III",
      "address_1": "Plot 22-110, Part Ii, Ida",
      "address_2": "Rangareddy, Jeedimetla",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1019-2018",
      "product_description": "Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.",
      "product_quantity": "18,288 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.",
      "recall_initiation_date": "20180718",
      "center_classification_date": "20180727",
      "termination_date": "20210715",
      "report_date": "20180808",
      "code_info": "Lot #: E180315, Exp 12/19"
    }
  ]
}